Associate Medical Director-Oncology (CAN)

Role Summary

• Provide 24/7 emergency medical support for medical and safety advice as needed
• Provide training to project teams on the medical aspects of the trial and therapeutic training, as needed
• Review of deviations from protocol
• Identify the risks related to the study and contribute to the development of the risk management plan

Review and understand the study medical deliverables as defined in the assigned study contract, with the support of more experienced colleagues, and contribute to monitoring budgetary expenditures throughout the studies assigned to them

• Attends and may be required to present at major therapeutic and drug development conferences
• Ensures good communication and maintains good relationships with (future) customers
• Contributes and participates, with support from more experienced colleagues if necessary, in customer evaluations, visits and offer presentations

Pour réussir dans ce poste, vous devrez posséder

• Un diplôme de docteur en médecine (MD)
• Expérience en tant qu’oncologue
• au moins trois ans d’expérience professionnelle pertinente, avec une solide expertise en oncologie
• Une bonne connaissance des normes GxP

Une situation en règle auprès des autorités de réglementation et d’agrément locales, provinciales (aux États-Unis) et nationales, ainsi qu’auprès des organismes de certification

• Connaissance des exigences réglementaires applicables (locales), notamment celles du RGPD/HIPAA, du CFR/CTR/CTD
• Excellentes compétences en communication écrite et verbale, y compris une bonne maîtrise de l’anglais
• Présentable, extraverti et axé sur le client
• Capacité à travailler dans l’environnement dynamique et stimulant d’une entreprise en pleine croissance
• Excellence administrative
• Maîtrise requise de divers logiciels tels que Word, Excel et PowerPoint

Avertissements

*Notre politique de travail hybride favorise un milieu de travail dynamique et prévoit deux journées de présence au bureau par semaine pour les employés résidant à une distance raisonnable de l’un de nos bureaux à l’échelle mondiale.

"L’équipe de recrutement d’ Allucent gère le processus de recrutement et d’embauche pour Allucent (US) LLC et ses sociétés affiliées (collectivement « Allucent »). Allucent n’accepte pas les CV non sollicités provenant de recruteurs tiers ni les demandes de collaboration non sollicitées concernant l’un de nos postes vacants. L’envoi de CV non sollicités à des employés d’ Allucent n’engage en aucun cas Allucent à embaucher ces personnes à l’avenir ni à verser une rémunération à une agence de recrutement tierce.

« Les candidats ne doivent en aucun cas être présentés directement à nos responsables de l'embauche, à nos employés ou au service des ressources humaines."

Responsibilities

In this role your key tasks will include

Independently provide medical monitor support to assigned clinical studies, for example answering medical questions from study team and/or site, assist with protocol interpretation and medical review of generated data including but not limited to clinical laboratory data and case report forms as necessary to ensure adherence to the protocol, consistency and scientific validity of the data. When appropriate, and with the necessary support from senior colleagues, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen

• Prepare the Medical Monitoring and other relevant plans for assigned studies conducted by Allucent prior to the start of the study and in accordance with deliverables contracted.
• Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events
• Assist clinical data management with MedDRA and WHO coding in assigned trials

Assist by reviewing clinical study documents for medical consistency and relevance, with support of senior medical team members if needed, including but not limited to the clinical trial protocol (CTP), the Informed Consent (ICF) and clinical study report (CSR) other safety reports (e.g., DSUR, PSUR)

• Assist in the set up and conduct of Data Safety Boards (DSMB, DMB or similar) and Dose escalation meetings (DEC)
• Attend, participate and present in Kick-Off, Investigators’ meeting, and other relevant meetings in assigned projects, as requested.
• Provide 24/7 urgent medical support for medical and safety advice if required
• Training of project teams on medical aspects of the trial and therapeutic training as required
• Review of Protocol Deviations
• Identify study risks and provide input to the Risk plan

Review and understand study medical deliverables laid down in the assigned study’s contract with support of senior colleagues and help track budget spent throughout their assigned study(ies)

• Attends and may need to present at major therapeutic conferences and drug development conferences
• Assure good communication and relationships with (future) clients
• Contribute and take part with support from senior colleagues as needed in client evaluations, visits and bid defenses

Requirements

To be successful you will possess

• MD degree
• Experience as an Oncologist
• Minimum 3 years of relevant work experience with solid Oncology expertise
• Good knowledge of GxP
• Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies
• GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements understanding
• Strong written and verbal communication skills including good command of English language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Administrative excellence
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required

Benefits

• Voici quelques-uns des avantages liés au fait de travailler chez Allucent :
• Ensemble complet d’avantages sociaux selon le lieu de travail
• Salaires concurrentiels selon le lieu de travail
• Budget de formation et d’études alloué par service pour favoriser le perfectionnement professionnel
• Horaires de travail flexibles (dans la mesure du raisonnable)
• Possibilité de travail à distance ou hybride* selon le lieu de travail
• Possibilités d’accéder à des postes de direction et de bénéficier d’un mentorat
• Participation à notre programme de jumelage, que ce soit en tant que nouvel employé ou employé déjà en poste
• Possibilités d’évolution interne et de progression de carrière
• Programme de recommandation de candidats par les employés, financièrement avantageux
• Accès à des formations en ligne sur les compétences générales et techniques via ADP et nos plateformes internes
• Admissibilité à notre programme de primes ponctuelles, qui récompense les efforts exceptionnels déployés dans le cadre de projets
• Admissibilité à notre programme de récompenses de fidélité, qui reconnaît la loyauté et l’engagement des employés de longue date

Benefits of working at Allucent include

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via ADP and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Additional Information

Disclaimers

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “ Allucent ”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”